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ObjectiveElectronic health record (EHR)-based shared decision-making (SDM) and clinical decision support (CDS) systems can improve cardiovascular disease (CVD) care quality and risk factor management. Use of the CV Wizard system showed a beneficial effect on high-risk community health center (CHC) patients’ CVD risk within an effectiveness trial, but system adoption was low overall. We assessed which multi-level characteristics were associated with system use.Materials and MethodsAnalyses included 80 195 encounters with 17 931 patients with high CVD risk and/or uncontrolled risk factors at 42 clinics in September 2018–March 2020. Data came from the CV Wizard repository and EHR data, and a survey of 44 clinic providers. Adjusted, mixed-effects multivariate Poisson regression analyses assessed factors associated with system use. We included clinic- and provider-level clustering as random effects to account for nested data.ResultsLikelihood of system use was significantly higher in encounters with patients with higher CVD risk and at longer encounters, and lower when providers were >10 minutes behind schedule, among other factors. Survey participants reported generally high satisfaction with the system but were less likely to use it when there were time constraints or when rooming staff did not print the system output for the provider.DiscussionCHC providers prioritize using this system for patients with the greatest CVD risk, when time permits, and when rooming staff make the information readily available. CHCs’ financial constraints create substantial challenges to addressing barriers to improved system use, with health equity implications.ConclusionResearch is needed on improving SDM and CDS adoption in CHCs.Trial RegistrationClinicalTrials.gov, NCT03001713, https://clinicaltrials.gov/

INTRODUCTION: The Cancer Health Assessments Reaching Many study seeks to reduce disparities in genomic care. Two patient advisory committees (PACs) were formed, 1 of English speakers and 1 of Spanish speakers, to vet study processes and materials. Stakeholder engagement in research is relatively new, and we know little about how stakeholders view their engagement. We wanted to learn how patient stakeholders viewed the process, to inform future patient engagement efforts. METHODS: Patients at 2 study sites were invited to serve on 2 PACs. We used an iterative engagement process to solicit and incorporate patient feedback. Much of the PAC feedback on study materials and processes was incorporated. Using surveys and exit interviews, we evaluated stakeholders’ experiences as PAC members. RESULTS: Nearly all PAC members felt satisfied and included in the study decisions, but surveys and exit interviews suggested the need to improve communications. DISCUSSION: Although most believed their feedback was used, and most felt included in study decisions, some said they did not know whether their opinions were used to modify materials or approaches. This suggests the need to explain to patient stakeholders the extent to which their feedback was used and to inform them about the impact that other stakeholders, such as institutional review boards, have on decisions. CONCLUSION: Our evaluation highlights the value of dedicating resources to stakeholder engagement. Although gathering patient feedback on study materials and processes introduced time constraints and complexity to our study, adaptations to materials and processes furthered study goals.

Management of cardiovascular disease (CVD) risk in socioeconomically vulnerable patients is suboptimal; better risk factor control could improve CVD outcomes.To evaluate the impact of a clinical decision support system (CDSS) targeting CVD risk in community health centers (CHCs).This cluster randomized clinical trial included 70 CHC clinics randomized to an intervention group (42 clinics; 8 organizations) or a control group that received no intervention (28 clinics; 7 organizations) from September 20, 2018, to March 15, 2020. Randomization was by CHC organization accounting for organization size. Patients aged 40 to 75 years with (1) diabetes or atherosclerotic CVD and at least 1 uncontrolled major risk factor for CVD or (2) total reversible CVD risk of at least 10% were the population targeted by the CDSS intervention.A point-of-care CDSS displaying real-time CVD risk factor control data and personalized, prioritized evidence-based care recommendations.One-year change in total CVD risk and reversible CVD risk (ie, the reduction in 10-year CVD risk that was considered achievable if 6 key risk factors reached evidence-based levels of control).Among the 18 578 eligible patients (9490 [51.1%] women; mean [SD] age, 58.7 [8.8] years), patients seen in control clinics (n = 7419) had higher mean (SD) baseline CVD risk (16.6% [12.8%]) than patients seen in intervention clinics (n = 11 159) (15.6% [12.3%]; P .001); baseline reversible CVD risk was similarly higher among patients seen in control clinics. The CDSS was used at 19.8% of 91 988 eligible intervention clinic encounters. No population-level reduction in CVD risk was seen in patients in control or intervention clinics; mean reversible risk improved significantly more among patients in control (-0.1% [95% CI, -0.3% to -0.02%]) than intervention clinics (0.4% [95% CI, 0.3% to 0.5%]; P .001). However, when the CDSS was used, both risk measures decreased more among patients with high baseline risk in intervention than control clinics; notably, mean reversible risk decreased by an absolute 4.4% (95% CI, -5.2% to -3.7%) among patients in intervention clinics compared with 2.7% (95% CI, -3.4% to -1.9%) among patients in control clinics (P = .001).The CDSS had low use rates and failed to improve CVD risk in the overall population but appeared to have a benefit on CVD risk when it was consistently used for patients with high baseline risk treated in CHCs. Despite some limitations, these results provide preliminary evidence that this technology has the potential to improve clinical care in socioeconomically vulnerable patients with high CVD risk.ClinicalTrials.gov Identifier: NCT03001713.

Introductory sentence indicating purpose of the study: Over the last three decades, incidence of colorectal cancer (CRC) has risen steadily among people younger than age 50 (early-onset) in many developed countries, including the United States. More information is needed about the causes of early-onset CRC and novel, pragmatic interventions are needed to ensure rapid identification of early-onset CRC cases through timely screening and symptoms detection. Brief description of pertinent experimental procedures: The Consortium for Research on Early-Onset Colorectal Cancer (CREO) is a partnership among scientists and clinicians at four data-contributing health systems: Kaiser Permanente Northwest, Kaiser Permanente Northern California, and Kaiser Permanente Colorado, and Henry Ford Health. CREO plans to assemble a novel cohort of 8 million adults (including 3,200 early-onset CRC cases diagnosed from 2010 through 2025) encompassing electronic health record, survey, and biospecimen data to conduct research that will identify and estimate the impact of approaches to rapidly detect early-onset CRC through screening and clinical practice. Using electronic health record data from our participating health systems, we identified individuals diagnosed with CRC between 2010 and 2020. Here, we describe demographic and tumor characteristics of individuals with CRC in this cohort, and compare those to national data obtained from the Surveillance, Epidemiology, and End-Results program for the years 2012 – 2016. Summary of the new, unpublished data: We identified 15,884 adults with CRC (1,932 with early-onset CRC and 13,912 with late-onset CRC) in the four participating CREO health systems. Individuals with early-onset CRC in the CREO cohort were non-Hispanic White (54%), Hispanic (18%), Asian-American (14%), and African American/Black (9%). The proportion of CREO cohort adults with early-onset CRC was 12%; this matched the proportion in the population-based SEER data. The proportion of diagnosed CRC cases located in the rectum was 29% in both the CREO cohort and in SEER data. Anatomic location for the remaining tumors varied slightly between the CREO cohort and SEER data: in CREO data, 22% were proximal colon cancers, and 31% were distal colon cancers; in SEER data, and 29% were proximal and 22% were distal. Statement of the conclusions: Our findings show that CREO’s assembled cohort of electronic health record data from multiple large health systems matches several key aspects of population-based data from SEER. Through CREO, we plan to create a comprehensive, multi-level dataset of a new, racially and ethnically diverse cohort of 8 million adults in order to elucidate factors associated with the alarming rise in early-onset CRC and identify interventions to ensure rapid identification and secondary prevention of early-onset CRC. Citation Format: Gloria D. Coronado, Andrea Burnett-Hartman, Jeffrey Lee, Carmit McMullen, Carolyn Rutter, Mary Ann McBurnie, Christine Neslund-Dudas, John Carethers. Building a data resource to advance research on early-onset colorectal cancer: The consortium for research on early-onset colorectal cancer (CREO) [abstract]. In: Proceedings of the AACR Special Conference on Colorectal Cancer; 2022 Oct 1-4; Portland, OR. Philadelphia (PA): AACR; Cancer Res 2022;82(23 Suppl_1):Abstract nr A011.

Background: The research enterprise has embraced patient centeredness in embedded efficient pragmatic trials, but limited data exist on using patient-reported outcomes (PROs) collected as part of u...

Lynch syndrome (LS) is the most common inherited cause of colorectal and endometrial cancers. Identifying individuals at risk for LS without personal cancer history requires detailed collection and assessment of family health history. However, barriers exist to family health history collection, especially in historically underserved populations. To improve LS risk assessment in historically underserved populations, we adapted the provider-facing PREdiction Model for gene Mutations (PREMM

BackgroundPrior studies show that family caregiver factors influence patient outcomes. The purpose of this analysis was to determine the association between family caregiver self-rated health, perception of preparedness and burden at the time of patient admission to home palliative care (HomePal) with downstream patient hospital utilisation and time to hospice enrolment and death.MethodsData for this cohort study (n=441) were drawn from a trial testing two models of HomePal. Caregiver self-rated health, preparedness (Preparedness for Caregiving Scale, CPS) and burden (Zarit-12) were measured at admission to HomePal. Caregivers were categorised as having good/very good/excellent or fair/poor health, scoring above or below the CPS median score (23), or having no/mild (0–10), moderate (11-20) or high (>20) burden. Proportional hazard competing risk models assessed the association between caregiver factors with hospital utilisation (emergency department visits, observation and inpatient stays).ResultsPatients whose caregivers reported poor health and low preparedness received more visits by home health aides and social workers, respectively (both, p0.05).ConclusionProspective studies are needed to understand how greater in-home supports for family caregivers with poor health could help achieve quality palliative care that aligns with families’ priorities.Trial registration numberNCT03694431; ClinicalTrials.gov.

Introduction: As health care systems strive to meet the growing needs of seriously ill patients with high symptom burden and functional limitations, they need evidence about how best to de...

Introduction: The Cancer Health Risk Assessments Reaching Many (CHARM) study (NCT03426878) aims to increase access to genetic testing for hereditary cancer in low-income, low-literacy, and minority populations (hereafter referred to as “underserved”). To implement the study, we have capitalized on the availability of electronic medical record (EMR) systems, developed innovative web-based tools, and designed a novel telemedicine protocol for return of clinical genetic testing results. Methods: Patients aged 18-49 years are recruited from two centers: Kaiser Permanente Northwest (KPNW; an integrated health care system in Portland, OR) and Denver Health (DH; a federally qualified health care center in Denver, CO). Specific protocols were developed to identify potentially eligible patients from the EMR and invite them to complete a web-based family history assessment. KPNW patients were recruited using email, text messaging, and in-clinic booths; DH patients were recruited via mail, phone, and provider referral. Validated risk assessment tools for Lynch syndrome (PREMM5) and heredity breast and ovarian cancer syndrome (B-RST) were adapted for our low-literacy and bilingual (English and Spanish) target population. Genetic testing is offered to patients with greater than average risk for hereditary cancer, or where risk cannot be assessed because of unknown family history or limited family structure. Eligible patients review a multipart, multimedia online consent. Those who consent to participate provide a saliva sample for clinical exome sequencing. Genetic counselors return results by telephone using traditional (usual care active comparator) or modified, communication-focused (experimental) counseling for pathogenic variants, likely pathogenic variants, and select variants of uncertain significance in 39 genes related to cancer risk, pathogenic variants in 79 genes related to medically actionable secondary findings, and 14 genes related to carrier status. Results: In the first four months of recruitment, 258 patients have completed the risk assessment tool (48% are underserved). Of those, 180 (70%) had greater than average risk of hereditary cancer (or limited family history information) and were invited to participate (53% were underserved); 86% of underserved patients and 78% of patients who do not meet criteria for the underserved category have consented. The vast majority of participants complete enrollment without assistance from study staff, and in-person visits are not required for participation. Telephone genetic test result disclosure will begin in December 2018. Conclusions: We have successfully developed online tools for cancer risk assessment that are accessible to underserved and low-literacy populations. These tools may be a cost-effective approach for improving the capture of family history data in the EMR. It does not require a provider to gather the information and the patient gets immediate feedback on results of the risk assessment and appropriate next steps. This abstract is also being presented as Poster A37. Citation Format: Heather Spencer Feigelson, Kathleen F. Mittendorf, Tia L. Kauffman, Katherine Anderson, Sonia Okuyama, Benjamin Wilfond, Gail P. Jarvik, Laura M. Amendola, Carmit McMullen, Fances Lynch, Donna Eubanks, Elizabeth Shuster, Jake Allen, Stephanie A. Kraft, Galen Joseph, Sandra Soo-Jin Lee, Katrina A.B. Goddard. Using web-based tools to assess familial cancer risk in diverse populations [abstract]. In: Proceedings of the AACR Special Conference on Modernizing Population Sciences in the Digital Age; 2019 Feb 19-22; San Diego, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(9 Suppl):Abstract nr PR02.

Despite rapid technical progress and demonstrable effectiveness for some types of diagnosis and therapy, much remains to be learned about clinical genome and exome sequencing (CGES) and its role within the practice of medicine. The Clinical Sequencing Exploratory Research (CSER) consortium includes 18 extramural research projects, one National Human Genome Research Institute (NHGRI) intramural project, and a coordinating center funded by the NHGRI and National Cancer Institute. The consortium is exploring analytic and clinical validity and utility, as well as the ethical, legal, and social implications of sequencing via multidisciplinary approaches; it has thus far recruited 5,577 participants across a spectrum of symptomatic and healthy children and adults by utilizing both germline and cancer sequencing. The CSER consortium is analyzing data and creating publically available procedures and tools related to participant preferences and consent, variant classification, disclosure and management of primary and secondary findings, health outcomes, and integration with electronic health records. Future research directions will refine measures of clinical utility of CGES in both germline and somatic testing, evaluate the use of CGES for screening in healthy individuals, explore the penetrance of pathogenic variants through extensive phenotyping, reduce discordances in public databases of genes and variants, examine social and ethnic disparities in the provision of genomics services, explore regulatory issues, and estimate the value and downstream costs of sequencing. The CSER consortium has established a shared community of research sites by using diverse approaches to pursue the evidence-based development of best practices in genomic medicine.

Colorectal cancer (CRC) is the third most common cancer in the United States. For some CRC patients, cancer treatment involves creating a permanent or temporary intestinal ostomy. Having an ostomy often results in complex social and physical concerns—including unpredictable and at times publicly noticeable bowel output. In this article, we discuss findings from 30 in-depth interviews with female CRC survivors with ostomies in the western United States. We highlight how having an ostomy disrupts culturally sanctioned practices of continence that mark the attainment of full-adult personhood. We discuss how survivors reclaim a sense of full personhood after ostomy surgery through a process of realignment that entails both learning how to manage ostomy equipment to conceal bowel activity and reappraising their illness and suffering. We suggest that the anthropological categories of personhood and personhood realignment be incorporated into research and interventions aimed at increasing support among cancer survivors living with bodily impairments.

To investigate best practices for implementing and managing clinical decision support (CDS) in community hospitals and ambulatory settings, we carried out a series of ethnographic studies to gather information from nine diverse organizations. Using the Rapid Assessment Process methodology, we conducted surveys, interviews, and observations over a period of two years in eight different geographic regions of the U.S.A. We first utilized a template organizing method for an expedited analysis of the data, followed by a deeper and more time consuming interpretive approach. We identified five major categories of best practices that require careful consideration while carrying out the planning, implementation, and knowledge management processes related to CDS. As more health care organizations implement clinical systems such as computerized provider order entry with CDS, descriptions of lessons learned by CDS pioneers can provide valuable guidance so that CDS can have optimal impact on health care quality.